Status:
UNKNOWN
An Observational Study of Pruritus Amongst Hemodialysis Patients
Lead Sponsor:
Acologix, Inc.
Conditions:
Pruritus
Kidney Failure, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this observational study is to better understand the natural history/natural course of uremic pruritus (UP) - itching associated with chronic kidney disease(CKD). During the lifetime of...
Eligibility Criteria
Inclusion
- Patients aged ≥ 18 years;
- Patients receiving chronic hemodialysis 3 or more times per week;
- Patients who have "mild", "moderate" or "severe" pruritus;
- "Mild" pruritus is defined as a nighttime or daytime worst itch intensity VAS \>10 mm and \< 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of \< 2;
- "Moderate" pruritus is defined as a nighttime or daytime worst itch intensity VAS \>10 mm and \< 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of ≥ 3;
- "Severe" pruritus is defined as a nighttime or daytime worst itch intensity VAS of ≥ 40 mm at Screening and a combined daytime and nighttime Kawashima Itch Severity Score of ≥ 3;
- Patients who are able to understand and complete questionnaires written in English;
- Patients who are expected to continue to dialyze at the present dialysis unit for the duration of the study.
Exclusion
- Patients who have pruritus attributed to causes other than chronic kidney disease (CKD) or the direct consequences of CKD (i.e., hyperparathyroidism, circulating "uremic toxins");
- Patients who have had significant alteration in their dialysis regimen within the 2 weeks prior to Screening (or those for whom such changes are anticipated during the study) are excluded. A "significant alteration" is defined as:
- A change in the type of hemodialysis filter;
- An increase or decrease in total duration of dialysis prescribed of \> 1 hour/week;
- A change in the site or type of venous access for dialysis;
- An increase or decrease in prescribed blood flow of \>100 mL/min;
- Patients who are unwilling to comply with the study protocol. Test Product, Dose, Mode of Administration and Duration of Treatment
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00715260
Start Date
December 1 2007
End Date
July 1 2008
Last Update
July 15 2008
Active Locations (5)
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1
Kidney Care Associates
Augusta, Georgia, United States, 30901
2
FMC Metaire
Metaire, Louisiana, United States, 70006
3
Western New England Renal Associates
Springfield, Massachusetts, United States, 01089
4
Southeast Renal Associates
Charlotte, North Carolina, United States, 28208